“Strangely, the public health community has not placed much priority on patent transparency, although it has often expressed concern about the effect of patents on medicine access.” [page 26]

According to a report in IP Watch, Reed Beall criticized the recent United Nations Secretary-General’s High Level Panel on Access to Medicines, saying “amazingly people were more interested in having the ideological debate than simply focusing and asking for the data that can tell us exactly where there might be medicines access problems so that action can be taken.” [Ideologies Fly In Discussion Of WIPO Pharma Report Calling For Less Ideology, Catherine Saez, IP-Watch, March 13, 2016]

In the Beall/Attaran paper [KEI's April 12, 2016 comment here: http://www.keionline.org/node/2467], and in the WIPO seminar discussions about the paper, the authors have held themselves out as more or less lonely voices calling for transparency of patent landscapes on essential medicines. This surprised and offended the many people who have not only been concerned about the lack of transparency on patent landscapes, but have been doing most of the work in digging out the facts, and/or proposing remedies.

The Beall/Attaran paper deals specifically with the WHO Essential Medicines List (EML), and the authors might make the argument that not much is known about the patent landscape of the entire EML, per se, but that really misses the point. There are many studies and commentaries on the patent landscape for medicines that are essential, including both those on and off the WHO EML. Much of the work in publishing patent landscapes in recent years has been done by MSF, I-Mak, and the Medicines Patent Pool, as well as several academics and health NGOs. NGOs, including but not limited to KEI, have also addressed policy issues related to the transparency of patent landscapes, not only for medicines, but also in other areas, including clean energy, climate change, and standards essential patents on mobile computing devices, for example.

Below are just a few of the many data points regarding transparency of patents, most of them on medicines. Few of these deal only with the WHO EML, for two well-known reasons.

First, from a historical perspective, the EML has generally avoided patented medicines. This includes the outdated version (2013, 18th Edition) that Beall and Attaran studied in their recent report.

Until the EML began to change its policies on patented medicines, continually looking to find patents on the EML was mostly about proving the obvious -- a list that avoided patented medicines had few patents.

Second, for those drugs that were likely to be patented, such as the drugs on the EML for HIV/AIDS, or more recently drugs for TB, HCV, and other illnesses where treatment efforts were being ramped up for medical reasons, studies have generally offered a deeper analysis focused on specific products, and the specific challenges of overcoming those patents, including patent evergreening on new formulations and new uses. There were also proposals to remedy the lack of transparency of patent landscapes.

This note addresses an exaggeration that seemed intended to portray groups concerned about patents and health as driven by ideological concerns, rather than an empirical approach. There have been extensive efforts for several years to improve the transparency of patent landscapes, involving many players. The work that Beall and Attaran dismiss as scattershot includes projects that have been the most important in overcoming patent barriers in places where they are consequential.

Annex: Some data points on the efforts to expand transparency of patent landscape

2016

2016 February 28. Discussion on transparency of ”Patent landscape” in Contribution To The United Nations Secretary­ General’s High Level Panel On Access To Medicines Increasing The Transparency Of Markets For Drugs, Vaccines, Diagnostics And Other Medical Technologies. Signed by 17 NGOs, 2 academics and 3 members of the European Parliament.http://keionline.org/sites/default/files/UN-HLP-A2M-Transparency-28Feb2016-Final.pdf

2015, November 23. KEI’s Initial Comments on the MPP/BMS license to patents and know-how for daclatasvir (DCV) http://keionline.org/node/2373. “In several areas, BMS is setting an important precedent, including the extensive transparency of the patent landscape for daclatasvir.”

2015 July 30. Written Statement of Knowledge Ecology International on Patents and Health at WIPO Standing Committee on the Law of Patents, SCP 22. http://keionline.org/node/2301. “The TPP also threatens to ban the effective implementation of liability rules, by create norms for the payment of damages that exceed current national laws and WTO TRIPS norms. We have published an article about this today in IP-Watch, highlighting the practical negative impact on this on the U.S. law to induce transparency of patents on biologic drugs. . .”

2015 July. Patent and licenses on antiretrovirals: A snapshot. UNITAID.

2015 July. Patent Landscape: elbasvir. UNITAID.

2015 July. Patent Landscape: grazoprevir. UNITAID.

2015 July. Patent Landscape: velpatasvir. UNITAID.

2015 July 10. KEI letter to HHS, regarding 3 issues in the TPP. http://keionline.org/node/2277. “The rationale for limiting damages in 35 U.S.C. 271(e)(6)(B) is to create an incentive for the biologic drug manufacturer to be more transparent about patent landscapes, and thus reduce the risks to the biosimilar drug company. The TPP would make the U.S. at risk for litigation under ISDS and sizable damages if this provision in the ACA is not changed.”

2014

2014 October. Patent Landscape Report on Animal Genetic Resources Prepared for the World Intellectual Property Organization By Paul Oldham, Stephen Hall, Colin Barnes, in cooperation with the Food and Agriculture Organization of the United Nations (FAO), http://www.wipo.int/edocs/pubdocs/en/wipo_pub_947_3.pdf

2011 November. Patent Landscape Report on Desalination Technologies and the Use of Alternative Energies for Desalination Prepared for the World Intellectual Property Organization by CambridgeIP - Helena van der Vegt, Ilian Iliev, Quentin Tannock, Sarah Helm, In cooperation with the International Renewable Energy Agency (IRENA) with participation of the Global Institute for Water, Environment and Health (GIWEH), http://www.wipo.int/edocs/pubdocs/en/patents/948/wipo_pub_948_2.pdf

2011 February 18. Meeting Code: WHO-WIPO-WTO/IP/MED/GE/11. Geneva, Switzerland. Access to Medicines, Patent Information and Freedom to Operate; a Technical Symposium. http://www.wipo.int/meetings/en/details.jsp?meeting_id=22322. The Beall/Attaran paper may have been related to this technical workshop, which explored the same issues. As one can observe from the video and the presentations, there were two basic camps at the meeting, those who were trying to promote greater transparency in the areas where patents were perceived to be a problem (i.e. Amin, Hoen, etc), and those more interested in claiming the lack of patents on the WHO EML was evidence that patents did not hurt patient access to drugs - the school of thought associated with the notion that poor people would not need new drugs.

WHO-WIPO-WTO/IP/MED/GE/11/REF/B5/LAING. The Patent Status of Medicines on the WHO Model List of Essential Medicines - Mr. Richard Laing The Patent Status of Medicines on the WHO Model List of Essential Medicines - Mr. Richard Laing.

2010 October 14. KEI proposed the WIPO SCP 15 create a cluster create a cluster of experts to examine: “Possible best practices or global norms for mandatory obligations to disclose patents relating to open standards for some essential information or energy technologies or other essential areas of technology.” http://keionline.org/node/978

2009

2009. Development Agenda project DA_19_30_31_01 (“Developing Tools for Access to Patent Information”) described in document CDIP/4/6, adopted by the Committee on Development and Intellectual Property (CDIP) at its fourth session held from November 16 to November 20, 2009.

The SCP could explore the creation of a multilateral mechanism administered by WIPO to share information on disputes over patent quality. This could include the creation of a database, possibly associated with the Patent Cooperation Treaty or through a separate instrument. The database could include information about administrative actions, such as patent reexaminations, as well as private litigation between parties, including both cases decided by the courts and those privately settled.

* The SCP could consider minimum standards for transparency of such disputes.

* The burden of disclosing information on patent challenges could be placed on patent owners.

The sanction for non-disclosure could be the non-enforcement of patent rights – an approach used in the United States when patent owners fail to disclose U.S. Government rights in patents that are based upon government funded research.

Background paper: James Love, “Measures to Enhance Access to Medical Technologies, and New Methods of Stimulating Medical R & D, UC Davis Law Review, Volume 40, Issue No. 3 Symposium: Intellectual Property and Social Justice, 679. An earlier version of this paper is found in James Love, “Four Practical Measures to Enhance Access to Medical Technologies,” in Negotiating Health (Pedro Roffe et al. Eds., cited below).

KEI notes that issues concerning standards are increasingly global concerns, involving goods and services that move in international trade across borders.

One issue that is very important and highlighted in the WIPO report concerns the disclosure (and non-disclosure) of patents relevant to the implementation of a proposed standard. When goods move in international trade, the systems for such disclosure cannot be based upon the laws of a single country, and there is a strong rationale for global norm-setting in this area.

Companies and patent owners who operate in good faith do not rely upon patent ambushes.

We note that many businesses believe that the current systems for disclosure are inadequate, in part because they do not extend outside of the membership of standard-setting bodies, and the disclosures that are made are often deliberately not helpful. Issues of standards are increasingly important for vast areas of the modern economy, including of course information, computing and telecommunications technologies and services, as well many other many other areas, such as certain energy and environmental technologies, and important elements of transportation technologies, to mention a few.

In March 2005, a multi-stakeholder group proposed a treaty on access to knowledge. This included a mechanism for managing disclosures on patents relevant to proposed standards.

2009 March 23. Knowledge Ecology International (KEI) organized a Briefing on Patents and Standards at WIPO’s 13th meeting of the Standing Committee on Patents (SCP), where the issue of disclosure of standards relevant pages was discussed. http://keionline.org/blogs/2009/03/23/scp-13-side-event, and provided this comment on SCP/12/3 Rev.2, Annex III, page 36:

Standard setting organizations have a legitimate interest in knowing before they adopt a standard if it will be free of patents, or if the patents relating to the standard will be licensed on reasonable terms. Increasingly this is a global problem. The Internet Engineering Task Force (IETF), the World Wide Web Consortium (w3c) and other bodies create global standards. They should know the entire global patent landscape before they act. At present there is no global framework that requires patent owners to disclose patents relevant to the standard.

In establishing standards for new technologies, protocols and platforms, it is generally the case that a standard setting organization (SSO) seeks disclosure of patent claims essential to the working of the relevant field of technology. If there exist relevant patent claims, the SSO will either (a) choose a different standard not encumbered by the patent, or (b) ask the patent owner to agree not to enforce existing or future patent claims against those implementing the standard, (c) request the patent holder to license the patent on a royalty-free basis, or (d) seek a commitment by the patent owner to license on reasonable and non-discriminatory (RAND) terms.

Patent owners are not currently required to disclose such patent claims, except in limited circumstances in some countries. For example, in the United States and some other countries, there is an expectation that patent owners must sometimes disclose patent claims when they are members of the body adopting the standard. This obligation is inadequate, however, because it does not exist in some countries, or to patent owners who are not active in the standard setting process.

The WIPO report highlights that tensions can arise between patents and standards with respect to the disclosure of patents “which become apparent when the implementation of a standard calls for the use of technology covered by one or more patents.” As the International Bureau has noted, current competition and legal remedies may not be enough to solve the inherent tensions that routinely arise in the realm of patents and standards. Reiterating our call at the 12th session of the WIPO SCP, WIPO should consider if the current systems of providing constructive notice regarding patent status to standards making bodies is working well in a global economy. WIPO should also consider whether or not it can facilitate global disclosures of patents on proposed standards, including a possible an instrument on patents and standards that would address both the issue of disclosure and remedies to non-disclosure, not only for members of standards-making organizations, but extending to third parties as well.

2008

2008 May. World Health Assembly (WHA) Global strategy and plan of action on public health, innovation and intellectual property (GSPOA). Resolution 61.21(Sixty-first). NGOs and others asked for action on greater patent transparency. The GSPOA as a result includes the following paragraph:

5.1.c. facilitate widespread access to, and promote further development of, including, if necessary, compiling, maintaining and updating, user-friendly global databases that contain public information on the administrative status of health-related patents, including supporting the existing efforts for determining the patent status of health products, in order to strengthen national capacities for analysis of the information contained in those databases, and improve the quality of patents;

2008 April 7-8. Life Sciences Symposium: Public Policy Patent Landscaping in the license sciences, organized by the World Intellectual Property Organization (WIPO) in cooperation with the Food and Agricultural Organization (FAO), April 7 and 8, 2008 at WIPO, 34, chemin des Colombettes, Geneva. http://www.wipo.int/meetings/en/2008/lifesciences/patent_landscaping/

As flawed as the Orange Book system is, however, it could easily be modified to work better. In particular, a listing of patents could be required or encouraged in various ways. For example, drug registration authorities could require or encourage the disclosure, without linking the disclosure to drug registration, by providing that patent owners could not enforce undisclosed patents against generic competitors. Although this approach would likely still result in the listing of patents of dubious quality or relevance, the drug registration authorities would not use the listing to block generic competitors. The patent owners would have to seek enforcements in national court systems, as is the case now in most countries, and everywhere for nonpharmaceutical inventions.

Regional or multilateral bodies concerned with health care, such as the African Union, the Pan American Health Organization, the World Bank, the Joint United Nations Program on HIV/AIDS, the Global Fund, regional patent pools, or the World Health Organization (“WHO”) could also play an important role in requiring or encouraging patent listings. For example, donors for AIDS treatments could meet with the handful of companies that develop key AIDS drugs and insist that they disclose the relevant patent numbers and countries where the patents are approved. This information could then be published on the Internet.

The task of disclosure could also be managed by local, regional, or multilateral patent offices, including the Patent Cooperation Treaty (“PCT”), which is administered by the World Intellectual Property Organization (“WIPO”). While patent offices have not played a traditional role in such disclosures, it is increasingly difficult to ignore the enormous problems presented by the lack of transparency of patent status.

One advantage of a global system would be the availability of information about the differences in the patent landscape for the same drug sold in different countries. Countries that face a high number of patents may seek to understand why such patents are not listed for other jurisdictions. The global authority could also do a more efficient job of “delisting” patents that are not relevant.

2005, May 10. A number of NGOs, including KEI, proposed a treaty on access to knowledge. The treaty proposal included and Article 6-2, on Disclosure obligations for patents relating to standards development organizations.